Adherence to Clinical Practice Guidelines for 7 Chronic Conditions in Long-term-Care Patients Who Received Pharmacist Disease Management Services Versus Traditional Drug Regimen Review

BACKGROUND: Numerous studies have shown that adherence to published clinical practice guidelines (CPGs) reduces disease morbidity and mortality. However, few benchmarks exist that demonstrate the rate of adherence to CPGs in patients in long-term-care facilities (LTCFs). OBJECTIVES: To evaluate CPG adherence in patients in LTCFs who received consultation from pharmacists who emphasize disease state management (DSM) compared with patients in other LTCFs who received traditional drug regimen review (DRR). METHODS: A retrospective chart review was conducted in November 2005 for 107 patients who received DSM services in 2 LTCFs and 304 patients who received DRR services in 4 LTCFs for the service period ending September 30, 2005. Chart review was conducted on all patients included in the current census as of September 1, 2005; residents were excluded from the analysis if they were discharged or deceased between September 1, 2005, and the date of chart review. CPG adherence was evaluated for the following 7 conditions: diabetes, coronary artery disease (CAD), stroke, heart failure (HF), hypertension, hyperlipidemia, and osteoporosis. In addition, the 6 most recent pharmacist recommendations for each patient were classified according to disease state. RESULTS: Adherence to CPGs was significantly better (all P>0.05) in patients receiving DSM services for the following performance measures for 4 of the 7 disease states: (1) diabetes: antiplatelet or warfarin use or contraindication for use (hypersensitivity or history of serious bleeding event), 89.7% for DSM services versus 71.0% for DRR services, and glycosylated hemoglobin (HbA1c) ²7% (86.2% vs. 62.0%); (2) CAD: antiplatelet use (88.2% vs. 56.1%), and angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use (82.4% vs. 40.9%); (3) HF: ACEI or ARB use (73.3% vs. 44.9%); and (4) osteoporosis: calcium use (85.0% vs. 56.3%). These observed differences in CPG adherence rates for patients receiving DSM services remained statistically significant after multivariate adjustment for likely confounders. Adherence to CPGs was not different between DSM and DRR facilities for the other 3 disease states (hypertension, hyperlipidemia, and stroke, P greater than 0.05). The mean number of pharmacist recommendations per patient per month was greater in DSM facilities (0.76) compared with DRR facilities (0.23, P less than 0.001). Pharmacists who provided DSM consultant services were more likely to make a recommendation to improve DSM (51.6%) than were pharmacists in the comparison facilities who provided traditional DRR services (31.7%, P less than 0.001). CONCLUSIONS: This self-evaluation of the provision of pharmacist consultant services that focus on disease management in addition to DRR found a higher rate of adherence to clinical practice guidelines for 4 of 7 common chronic disease states in long-term-care patients compared with patients who received only traditional DRR services.

y age 75, the average American has 2 or 3 chronic medical conditions. 1 When patients have multiple disease states, overall management of care can be challenging and costly. Therefore, adherence to established clinical practice guidelines (CPGs) becomes extremely important. Numerous studies have shown that adherence to CPGs has benefits of reducing disease morbidity and mortality and overall treatment costs. [2][3][4][5] In 2003, more than 1.3 million Americans were residents of long-term-care facilities (LTCFs). 6 A 1995 report found that 28% of residents will be hospitalized at least once during an average long-term-care (LTC) stay, with heart disease as the most common discharge diagnosis in patients older than 65 years. 7 In addition to having frequent hospitalizations, this patient population is commonly prescribed a large number of medications. A national survey of 878 nursing facilities conducted in 1997 found that residents received an average of 5.85 routine and 3.03 as-needed (PRN [pro re nata]) medication orders. 8 Even with this sizable population with high medication use, few standards exist for determining adequacy of care in the delivery of disease state management (DSM) services, specifically in LTCFs. A 2001 report by the Institute of Medicine, Improving the Quality of Long-Term Care, concluded that few standard measurement tools exist for assessing quality of care in these LTC patients. 9 In addition, an extensive literature search using the keywords "practice guidelines," "guideline adherence," and "long-term care" revealed only 2 published reports of adherence to recommended CPGs in this population. 10,11 BACKGROUND: Numerous studies have shown that adherence to published clinical practice guidelines (CPGs) reduces disease morbidity and mortality. However, few benchmarks exist that demonstrate the rate of adherence to CPGs in patients in long-term-care facilities (LTCFs).
OBJECTIVE: To evaluate CPG adherence in patients in LTCFs who received consultation from pharmacists who emphasize disease state management (DSM) compared with patients in other LTCFs who received traditional drug regimen review (DRR).

METHODS: A retrospective chart review was conducted in November 2005
for 107 patients who received DSM services in 2 LTCFs and 304 patients who received DRR services in 4 LTCFs for the service period ending September 30, 2005. Chart review was conducted on all patients included in the current census as of September 1, 2005; residents were excluded from the analysis if they were discharged or deceased between September 1, 2005, and the date of chart review. CPG adherence was evaluated for the following 7 conditions: diabetes, coronary artery disease (CAD), stroke, heart failure (HF), hypertension, hyperlipidemia, and osteoporosis. In addition, the 6 most recent pharmacist recommendations for each patient were classified according to disease state.
RESULTS: Adherence to CPGs was significantly better (all P <0.05) in patients receiving DSM services for the following performance measures for 4 of the 7 disease states: (1) diabetes: antiplatelet or warfarin use or contraindication for use (hypersensitivity or history of serious bleeding event), 89.7% for DSM services versus 71.0% for DRR services, and glycosylated hemoglobin (HbA1c) ≤7% (86.2% vs. 62.0%); (2) CAD: antiplatelet use (88.2% vs. 56.1%), and angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use (82.4% vs. 40.9%); (3) HF: ACEI or ARB use (73.3% vs. 44.9%); and (4) osteoporosis: calcium use (85.0% vs. 56.3%). These observed differences in CPG adherence rates for patients receiving DSM services remained statistically significant after multivariate adjustment for likely confounders. Adherence to CPGs was not different between DSM and DRR facilities for the other 3 disease states (hypertension, hyperlipidemia, and stroke, P >0.05). The mean number of pharmacist recommendations per patient per month was greater in DSM facilities (0.76) compared with DRR facilities (0.23, P <0.001). Pharmacists who provided DSM consultant services were more likely to make a recommendation to improve DSM (51.6%) than were pharmacists in the comparison facilities who provided traditional DRR services (31.7%, P <0.001).
We have defined DSM as the provision of therapeutic recommendations to improve CPG adherence for common chronic medical conditions, which we have practiced since we began our LTCF pharmacist consulting service in 2001. In addition, we have delivered the traditional drug regimen review (DRR) process, which is defined in federal regulations as evaluating indications for medication use, effectiveness of therapeutic goal, medication dose, presence of monitoring and duplicate therapy, and potential for adverse drug reactions. 12 We previously evaluated physician acceptance and perceived value of the pharmacist consultant interventions for 155 LTCF patients during an 8-month period. 13 Results showed that 523 of 559 recommendations (84.3%) were accepted by physicians and that 45% of recommendations were perceived as important by physicians. While 10.4% of pharmacist recommendations were made in response to federal guidelines in the DRR process, an additional 85.2% of recommendations were initiated as a result of a broader medication review, including DSM activities. These results demonstrated that our pharmacist recommendations were accepted and valued by physicians, but they did not allow us to evaluate the CPG adherence rates for the patients we served.
The objectives of this study were to evaluate (1) the end outcome of CPG adherence and (2) the process outcome of the number of care recommendations made for patients from LTCFs who received DSM pharmacy consulting services compared with patients who received traditional DRR pharmacy consulting services.
ss Methods

Study Design
A retrospective chart review was conducted on 411 patients at 6 LTCFs. Two facilities (107 patients) received DSM consultant pharmacist services (provided by Kristin K. Horning and James D. Hoehns) and 4 facilities (304 patients) received traditional DRR services. The 4 DRR (control) facilities constituted a convenience sample located within 30 miles of the 2 LTCFs that had consultant DSM pharmacy services. These control LTCFs had varying types of pharmacist consulting services, with 2 homes receiving corporate services (218 patients) and 2 homes receiving independent pharmacist consulting services (86 patients). While the homes receiving DSM services were both for-profit, 2 control homes were for-profit and 2 homes were nonprofit. All homes had both Medicare and Medicaid participation. The investigators believed that the control homes were a representative mix of usual pharmacist consulting services in our geographic area. Approval for the design and methodology of the study was obtained from both an institutional review board and from each LTCF administrator.

Patient Selection and Data Collection
All current residents admitted before September 1, 2005, were included in the analysis. Residents were excluded from the analysis if they were discharged or deceased between September 1, 2005, and the date of chart review. No patient charts were excluded because of poor documentation. A standard data collection form was used to record the following information for patient characteristics and clinical condition: patient age, gender, weight, admission date, functional status, number of scheduled and PRN medications, number of diagnoses, and presence of disease states. If a resident was diagnosed with more than 1 disease state, the subject was evaluated for all diagnoses and associated disease states. Disease state information for each resident was collected from section I1 of the full Minimum Data Set (MDS) version 2.0. Information on functional status for each resident was obtained from section G1 of the most recent quarterly MDS version 2.0. The MDS is a tool mandated by the Centers for Medicare & Medicaid Services (CMS) to record specific resident information, such as  diagnoses and functional ability. One purpose of the MDS, which is updated at least quarterly, is to identify potential health problems. 14 The 7 specific disease states that were analyzed were diabetes, coronary artery disease (CAD), stroke, heart failure (HF), hypertension, hyperlipidemia, and osteoporosis. These disease states were chosen because they are common in the elderly, are associated with high rates of morbidity and mortality, and have well-established CPGs. [15][16][17][18][19][20][21][22][23] Chart abstraction was conducted during November 2005 by Horning. The most recent laboratory data that pertained to the 7 disease states and performed between April 1, 2004, and September 30, 2005, were recorded from the medical charts. A maximum of 8 blood pressure measurements performed between August 2005 and September 2005 were extracted, and the average of these readings was calculated. This time frame was chosen to allow at least 2 months for consultant pharmacists to make recommendations and for laboratory tests to be performed on newly admitted patients. If no laboratory data or blood pressure measurements were found for patients with diagnoses of either diabetes or hypertension, the patients were considered to be not at goal. Since few patients had a documented diagnosis of hyperlipidemia, only patients with a diagnosis of either CAD and/or diabetes and with the results available for lipid laboratory panels were assessed with respect to CPG adherence for hyperlipidemia.
Assessment of CPG adherence for each disease state was based on the most recently accepted practice guideline, as summarized in Table 1 (Table 3). For patients with diabetes, significantly more DSM patients were receiving an antiplatelet agent, warfarin, or were recognized with a contraindication (hypersensitivity or history of major bleeding event, 89.7% vs. 71.0%; P <0.05). Diabetic patients on warfarin were recognized for CPG adherence because the current CPGs do not mandate that these diabetic patients also need to be on concomitant antiplatelet agents. 25 More patients with diabetes receiving DSM had glycosylated hemoglobin (HbA1c) controlled to <7% than did those in traditional DRR homes (86.2% vs. 62.0%; P <0.05).
In patients with CAD, significantly more patients receiving DSM were using aspirin or clopidogrel (88.2% vs. 56.1%; P <0.05) and an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) (82.4% vs. 40.9%; P <0.05). More patients with HF receiving DSM were prescribed an ACEI or ARB (73.3% vs. 44.9%; P <0.05). Patients with osteoporosis receiving DSM were more likely to be prescribed calcium supplementation (85.0% vs. 56.3%; P <0.05). CPG adherence was similar between DSM and traditional DRR groups for hypertension, hyperlipidemia, and stroke. These rates were also compared with the Health Disparities Collaboratives (HDCs), which provide goal rates of CPG adherence for specific measures in chronic care patients seen by practitioners in the primary care setting. 26,27 CPG adherence rate benchmarks specifically for LTCF patients have not been addressed by the HDC. However, in our study, patients receiving DSM services met the recommended goal benchmark for 4 of 6 HDC measures and were within 6% of meeting the goal for the remaining 2 HDC measures.
A total of 349 pharmacist recommendations in DSM facilities and 445 recommendations in traditional DRR facilities were analyzed by Horning. Consultant pharmacist recommendations between DSM and DRR pharmacists are summarized in Table 4. The mean number of pharmacist recommendations per patient per month was greater in facilities with DSM services compared with DRR facilities by a 3-to-1 ratio (0.76 vs. 0.23, P <0.001).

Adherence to Clinical Practice Guidelines
Pharmacists who delivered DSM services were more likely to make a recommendation to improve disease management (51.6%) than were pharmacists in comparison facilities who delivered only DRR services (31.7%, P <0.001). Although pharmacists providing DRR services had a higher percentage of recommendations on Beers criteria and/or federal regulations, the mean number of recommendations per patient per month regarding this category was actually greater in facilities receiving DSM services (0.21 vs. 0.12, P <0.001).
Further analysis of pharmacist recommendations showed that, for 4 of the 7 disease states, patients receiving DSM services had significantly more recommendations. Results of this analysis are summarized in Table 5. For example, 65.5% of diabetic patients receiving DSM had at least 1 of the 6 most recent consultant pharmacist recommendations pertaining to diabetes compared with 7.0% of patients receiving traditional DRR consultant services.
Logistic regression analysis was conducted for all measures, with significant differences found in CPG adherence rates between DSM and traditional DRR facilities (Table 6). Since the difference in use of antiplatelet or anticoagulation therapy in stroke patients was close to significant (P = 0.096) in the univariate analyses, this measure was also included in the multivariate analyses. The variable of DSM consulting services was significant in the following conditions: (1) diabetes patients receiving antiplatelet or warfarin or with a contraindication, and the last HbA1c <7% value; (2) CAD patients receiving aspirin or clopidogrel, and receiving ACEI or ARB; (3) HF patients receiving ACEI or ARB; and (4) osteoporosis patients receiving calcium supplementation. Overall, patients receiving DSM services were almost 4 to more than 7 times more likely to meet the criteria in CPGs than patients receiving traditional DRR. These findings further support the theory that DSM facilitates CPG adherence, even after adjusting for potential confounders. For patients with osteoporosis, adherence rates decreased significantly as the number of diagnoses increased. This finding may suggest that treatment of osteoporosis is considered a lower priority when multiple other disease states are present.

ss Discussion
Our study evaluated DSM in LTCF patients based on CPGs and whether pharmacist DSM consulting services improved guideline adherence. Zarowitz et al. in an unpublished study, presented as an abstract, found results similar to our study. 11 A pharmacist-led interventional program in more than 110,000 LTCF residents showed that patients with diabetes were more likely to adhere to diabetes management goals than benchmarks in younger (<65 years) noninstitutionalized patients: more than 85% of LTCF residents had HbA1c values of <8.0%, while the National Committee for Quality Assurance (NCQA) reported that 32.0% of younger, noninstitutionalized patients had HbA1c values >9.0%. 11 On the basis of these data, perhaps elderly LTCF patients with diabetes are better controlled than other noninsti-  The importance of adhering to CPGs in LTCF patients is somewhat controversial. A recent study suggests that improving CPG adherence may not decrease the incidence of cardiovascular events or prolong life. 28 In addition, LTCF patients may have a shorter life expectancy, since the average length of stay for an LTCF patient before becoming deceased or discharged is 892 days. 29 However, it is known that adherence to CPGs has dual benefits of cost reduction and decreased mortality in patients not residing in LTCFs. 2-5 Some of these benefits specifically seen in patients with diabetes, CAD, HF, hypertension, and osteoporosis are highlighted by NCQA, which has published reports of both adherence to and savings from using CPGs in Medicare and Medicaid patients. 2 Some have noted that the majority of CPGs focus on a single disease state and fail to address age or comorbidities. 29 It has also been proposed that multiple treatments could lead to more complex and costly drug regimens and a higher risk of drug interactions. 30 Despite LTCF patients possibly having a shorter life expectancy, 6 it is still rational and likely cost effective to optimize drug therapy for chronic conditions. A review of randomized clinical trials evaluated the effect of ACEIs on morbidity and mortality in HF patients, finding the greatest benefit within the first 3 months of therapy, which suggests that treatment may be beneficial even in this group of patients with a shorter life expectancy. 3 CMS currently mandates that a pharmacist conduct a monthly DRR at each LTCF. The purpose of the review is to evaluate medications for indications and reasons for use, effectiveness, dose, monitoring, duplicate therapy, and presence of adverse drug reactions or side effects. 12 However, consultant pharmacists adhering to these federal regulations may not advocate CPG adherence, as is suggested by the results of our study for the DRR group.

Logistic Regression Analysis of Clinical Practice Guideline Adherence
Others have also examined the need for a more thorough DRR. In 2002, Harjivan et al. proposed the enhanced drug regimen review (eDRR) model. This eDRR model emphasizes clinical interventions and patient outcomes by incorporating the pharmaceutical care plan into the review process, in which CPGs are included. 14 The eDRR requires that pharmacists providing LTC consultant services be certified in geriatric pharmacotherapy. 14 In our study, pharmacists providing DSM services were not certified as geriatric pharmacotherapy specialists.
Previous studies have demonstrated the value of pharmacist consulting services at LTCFs. In 1997, results of phase 1 of the Fleetwood Project estimated that pharmacist consultants improved therapeutic outcomes, which investigators defined as an absence of drug-related problems, by 43% and saved $3.6 billion per year in costs associated with drug morbidity and mortality from avoided drug-related problems. 31 However, the practical use of these findings is limited since they were based on a hypothetical group of 100 LTCF patients.
Despite pharmacist intervention, adequate DSM remains a challenge, in part because of multiple comorbid conditions in the population of LTCF residents. In the current study, the DSM group had a mean of 7.1 diagnoses, two thirds of patients had at least 1 psychiatric diagnosis, 57.0% received antidepressants, 25.2% received antipsychotics, and the mean number of antihypertensive medications was 2.1.

Limitations
First and foremost among the limitations of this study was that the chart abstraction and analysis of pharmacist interventions was completed by the authors, and they could not be blinded to the source of the medical charts from DSM versus DRR facilities. Second, the primary abstraction of data from the medical charts was performed by only 1 person (Horning), who was also 1 of the 2 pharmacists who provided the DSM services.
Third, this study was a retrospective analysis of data contained in patient charts, and the extent of documentation varied among facilities. Fourth, we had been providing DSM services in the 2 facilities since 2001 and were therefore unable to measure improvement in a prepost type of 2-by-2 comparative analysis between the DSM group and the DRR group. Fifth, for some disease states, only low numbers of cases for logistic regression analysis were available. Sixth, the data available to analyze hyperlipidemia treatment were limited since fasting lipid panels are generally performed and recorded as infrequently as once per year and many medical charts had no recorded data for lipid values.
It is also important to recognize that we measured intermediate clinical outcomes and not endpoint outcomes. While the DSM intervention influenced these process outcomes of care, we do not know if the improved process outcomes translate into measurable endpoint outcomes, including quality of life. We also did not report in the current study the physician acceptance rate of DSM or DRR recommendations.
Finally, pharmacist time spent at DRR facilities and payment for their services were not evaluated. However, we previously evaluated the time spent by consultant pharmacists providing DSM services in LTCFs over an 8-month period and determined that consultant pharmacists spent an average of 11.6 minutes per patient per month. 13 Currently, LTCFs do not have financial or other incentives to adhere to CPGs. LTCFs pay for DRR services based solely on adherence to federal guidelines, and the focus is on inappropriate medication use. The incentive for performing adequate DRR is sizable since there are potential penalties in the form of deficiencies for poor adherence to these measures. There are no current incentives for LTCFs to pay for DSM services, and the present study did not find savings in direct drug costs associated with DSM services compared with DRR services.

ss Conclusions
This self-evaluation of adherence to CPGs for 7 chronic diseases